The following data is part of a premarket notification filed by Abiomed, Inc. with the FDA for Abiomed Periotemp(tm) Probe.
| Device ID | K885075 |
| 510k Number | K885075 |
| Device Name: | ABIOMED PERIOTEMP(TM) PROBE |
| Classification | Gauge, Depth, Instrument, Dental |
| Applicant | ABIOMED, INC. 33 CHERRY HILL DR. Danvers, MA 01923 |
| Contact | Param I Singh |
| Correspondent | Param I Singh ABIOMED, INC. 33 CHERRY HILL DR. Danvers, MA 01923 |
| Product Code | EIL |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-08 |
| Decision Date | 1989-02-13 |